28 research outputs found

    Sample-size estimation is not reported in 24% of randomised controlled trials of inflammatory bowel disease: A systematic review

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    Background Sample-size estimation is an important factor in designing a clinical trial. A recent study found that 65% of Cochrane systematic reviews had imprecise results. Objective This study set out to review the whole body of inflammatory bowel disease (IBD) randomised controlled trials systematically in order to identify the reporting of sample-size estimation. Methods We conducted a comprehensive hand search of the Cochrane Library and Cochrane IBD Specialized Trials Register. We extracted information on relevant features and the results of the included studies. We produced descriptive statistics for our results. Results A total of 242 randomised controlled trials were included from 44 Cochrane systematic reviews. About 25% of the studies failed to report on sample-size estimation. Of those that did report on sample-size estimation, 33% failed to recruit their target sample size. Conclusions Around half of the randomised controlled trials in IBD either do not report sample-size estimation or reach their recruitment target with the level of detail in reporting being limited

    Probiotics for maintenance of remission in ulcerative colitis

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    Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first‐ or second‐line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response

    Dietary interventions for functional abdominal pain disorders in children: a systematic review and meta-analysis

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    Background Functional abdominal pain disorders (FAPDs) are common among children and are associated with decreased quality of life and school attendance. Several dietary interventions have been suggested to improve symptoms of FAPDs. This systematic review assessed the efficacy and safety of dietary interventions for pediatric FAPDs. Design and methods Electronic databases were searched (inception–October 2021). Systematic reviews or RCTs were included if children (4–18 years) with FAPDs were treated with dietary interventions and compared to placebo, no diet or any other diet. Data extraction and assessment of quality of evidence based on GRADE system was independently performed by two review authors. Outcomes were treatment success, pain intensity and frequency, and withdrawal due to adverse events. Results Twelve articles were included, representing data of 819 pediatric FAPD patients. Trials investigating fibers, FODMAP diet, fructans, fructose-restricted diet, prebiotic (inulin), serum-derived bovine immunoglobulin, and vitamin D supplementation were included. We found very low-certainty evidence that the use of fibers leads to higher treatment success (NNT = 5). Conclusion Based on current evidence, the use of fibers can be discussed in daily practice. High-quality intervention trials are highly needed to investigate if other dietary interventions are effective in the treatment of pediatric FAPD

    Interventions for treating iron deficiency anaemia in inflammatory bowel disease: a network meta-analysis

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    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective will be to evaluate the efficacy and harms of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease and rank the treatments in order of effectiveness in a network meta‐analysis

    P056 Power Calculations in Randomised Controlled Trials of Inflammatory Bowel Disease

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    Background: Sample size estimation is a vitally important calculation to make when designing a clinical trial. 25% of randomised controlled trials (RCTs) on interventions for Inflammatory Bowel Disease (IBD) have no power calculation (PC). We set out to systematically review RCTs reporting interventions for the management of IBD and to use the actual clinical data across these comparisons to produce data for minimum sample sizes that would achieve appropriate power. Methods: We included RCTs investigating any form of therapy for the treatment of IBD in patients of any age and interventions for either induction or maintenance of remission against control, placebo, or no intervention. The relevant data was extracted, and the studies were grouped according to the intervention used. We recalculated sample size and the achieved difference, as well as minimum sample sizes needed in the future. Results: A total of 105 trials were included. There was a large discrepancy between the estimated figure for the minimal clinically important difference used for power calculations and the actual differences seen. The minimum sample sizes to use in future trials were proposed based on the calculations made from actual achieved clinical differences from previous studies. Conclusion: A third of intervention studies in IBD within the last 25 years are underpowered, with large variations in the calculation of sample sizes. The resource containing sample size estimates constructed on the published evidence base is required for future researchers and key stakeholders within the IBD trial field

    Minimum sample size estimates for trials in inflammatory bowel disease: A systematic review of a support resource

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    Of 25% of randomised controlled trials (RCTs) on interventions for inflammatory bowel disease (IBD) have no power calculation. To systematically review RCTs reporting interventions for the management of IBD and to produce data for minimum sample sizes that would achieve appropriate power using the actual clinical data. We included RCTs retrieved from Cochrane IBD specialised Trial register and CENTRAL investigating any form of therapy for either induction or maintenance of remission against control, placebo, or no intervention of IBD in patients of any age. The relevant data was extracted, and the studies were grouped according to the intervention used. We recalculated sample size and the achieved difference, as well as minimum sample sizes needed in the future. A total of 105 trials were included. There was a large discrepancy between the estimated figure for the minimal clinically important difference used for the calculations (15% group differences observed 30% used for calculation) explaining substantial actual sample size deficits. The minimum sample sizes indicated for future trials based on the 25 years of trial data were calculated and grouped by the intervention. A third of intervention studies in IBD within the last 25 years are underpowered, with large variations in the calculation of sample sizes. The authors present a sample size estimate resource constructed on the published evidence base for future researchers and key stakeholders within the IBD trial field. [Abstract copyright: ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.

    P324 Tacrolimus for induction of remission in refractory ulcerative colitis: a Cochrane systematic review

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    Abstract Background There is a limited number of treatment options for patients with corticosteroid refractory ulcerative colitis (UC). We aimed to evaluate tacrolimus for induction of remission in these patients. Methods MEDLINE, Embase, CENTRAL, Clinicaltrials.gov and ICTRP were searched up to October, 2021 to identify all relevant randomised contolled trials (RCTs). The authors independently reviewed potentially relevant studies to determine eligibility based on pre-specified criteria. A data extraction form was developed and used to extract data from included studies. Data were analysed using Review Manager. The primary outcomes were induction of remission and clinical improvement, as defined by the studies. Results Five RCTs were included with a total of, 347 participants with active UC. There is low certainty (oral and rectal) tacrolimus may be superior for clinical remission when compared to placebo (14/87 to, 1/61, RR, 3.76, 95% CI, 1.03 to, 13.73). There is low certainty (oral and rectal) tacrolimus may be superior for clinical improvement when compared to placebo (45/87 to, 7/61, RR, 4.47, 95% CI, 2.15 to, 9.29. The results on adverse events are of very low certainty and no conclusions can be drawn. There is low certainty there may be no difference in achievement of clinical remission when tacrolimus suppositories (16/44) were compared to beclomethasone (15/44) (RR, 1.07, 95% CI, 0.60 to, 1.88). There is low certainty there may be no difference in clinical improvement when tacrolimus suppositories (22/44) were compared to beclomethasone (22/44) (RR, 1.00, 95% CI, 0.66 to, 1.88). There is low cerainty there may be no difference in serious adverse events when tacrolimus suppositories (1/44) were compared to placebo suppositories (0/44) (RR, 1.00, 95% CI, 0.13 to, 71.70) and total adverse events (21/44 to, 14/44) (RR, 1.50, 95% CI, 0.88 to, 2.55). The evidence on the efficacy and safety of tacrolimus compared to cyclosporine is of very low quality and no conclusions can be drawn. Conclusion The cohorts studied are small, with missing data sets, short follow-up, and the clinical endpoints used are not in line with those suggested by regulatory bodies. No clinical practice conclusions can be made.This review highlights the need for further research that targets relevant clinical questions, uses appropriate trial methodology, and reports key findings in a systematic manner that facilitates future integration of findings with current evidence to better inform clinicians and patients. Future studies need to be adequately powered and of pertinent duration to capture the effectiveness of tacrolimus in the medium-to-long term. Well-structured efficacy studies need to be followed up by long-term phase, 4 extensions to provide key outputs and inform a real-world setting
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